Abstract: The method of the present invention relates to treating female urinary incontinence and involves passing opposite ends of a tape into a female patient's body and then positioning at least a portion of the tape between the vaginal wall and the urethra, whereby the tape forms a supportive loop beneath the urethra. The ends of the tape are extended through the patient's abdominal wall and outside of the patient's body and then the position and tension of the supportive loop are adjusted to achieve a clinically acceptable degree of urinary continence.

Abstract: A surgical assembly and method for treating female urinary incontinence. The assembly includes a substantially flat, flexible tape having first and second ends, wherein at least a portion of the tape is adapted to be permanently implanted into a female patient's body as a loop beneath the urethra. The assembly further includes a flexible sheath having a first portion covering a first length of the tape and a second portion covering a second length of the tape. The first and second portions substantially cover the entire length of the implant portion of the tape prior to implantation of the tape and sheath combination into the patient's body. Following implantation into the patient's body, the first and second portions of the sheath are removable from the first and second ends of the tape respectively.

Abstract: A method is provided for assessing urinary function including removably coupling a first test module to a portable control device, selecting from a plurality of different tests a first test to assess urinary function, the selection being made based on first module identification information obtained by the control device from the test module, and performing the first test. The method may also include one or more of the steps of inserting an insert member coupled to the first test module at least partially into a patient's urinary tract, infusing fluid through the insert member into the urinary tract, and measuring pressure within the urinary tract as fluid is infused therein.

Abstract: The invention relates to a surgical instrument and a method for treating female urinary incontinence. A tape or mesh is permanently implanted into the body as a support for the urethra. In one embodiment, portions of the tape comprise tissue growth factors and adhesive bonding means for attaching portions of the tape to the pubic bone. In a further embodiment, portions of the tape comprise attachment means for fastening portions of the tape to fascia within the pelvic cavity. In both embodiments the tape is implanted with a single incision through the vaginal wall.

Abstract: A woven mesh is provided for supporting tissue or an organ within a female patient's pelvis, and a method for using the same. The mesh includes a central portion having a width, a length, first and second ends, and first and second side edges, and first and second wing portions extending from the first and second ends of the central portion respectively. The first and second wing portions each have a width, a length, and first and second peripheral edges. The width of the wing portions are each greater than the width of the central portion, and when positioned within the female patient, the central portion is positioned below and supports the tissue or organ. A mesh is also provided having woven fibers with voids therebetween, and having a central portion and first and second ends. The average size of the voids at least in the central portion is at least 25–50 mm2, and when positioned within the patient, the central portion is positioned below and supports the tissue or organ.

Abstract: A medical system is provided for assessing urinary function. The system includes a control device and at least one test module capable of being removably coupled to the control device such that, when coupled, the system is capable of performing a test to assess urinary function. The control device may include a processor and memory having stored therein a plurality of software subroutine, at least one of which directs a test to assess urinary function. The test module may include a module identification device, and the control device selects the software subroutine based upon information obtained from the module identification device. The test module may further include a tubing assembly forming a first fluid conduit between a first fluid inlet and a first fluid outlet and an insert member dimensioned for at least partial insertion into a patient's urinary tract and coupled to the first fluid outlet so that fluid infused through the first fluid conduit flows through the insert member.

Abstract: A test module is provided for coupling with a control device to form a portable system for assessing urinary function. The test module includes a test module housing, at least one coupling element for removably coupling the test module to the control device, a tubing assembly located at least partially within the test module housing, and a pressure interface in fluid communication with at least a portion of the tubing assembly. When the test module is coupled to the control device, the pressure interface is positioned relative to a pressure sensor in the control device so as to transmit pressure data thereto. The tubing assembly may also couple with a pump device in the control device so as to enable the pump device to pump fluid through the tubing assembly.

Abstract: Described is a surgical instrument and method for treating female urinary stress incontinence. The instrument includes a first curved needle-like element defining in part a curved shaft having a distal end and a proximal, a tape, or mesh, for implanting into the lower abdomen of a female to provide support to the urethra; a second curved needle element having a proximal end and a distal end, and a coupler for simultaneous attachment to the distal end of the first needle and the distal end of the second needle. In an alternate embodiment, the second curved needle is an anesthesia needle and the method includes anesthetizing the needle pathway through a patient's body to facilitate the passage of the first needle and mesh therethrough.

Abstract: A surgical assembly and method for treating female urinary incontinence. The assembly includes a substantially flat, flexible tape having first and second ends, wherein at least a portion of the tape is adapted to be permanently implanted into a female patient's body as a loop beneath the urethra. The assembly further includes a flexible sheath having a first portion covering a first length of the tape and a second portion covering a second length of the tape. The first and second portions substantially cover the entire length of the implant portion of the tape prior to implantation of the tape and sheath combination into the patient's body. Following implantation into the patient's body, the first and second portions of the sheath are removable from the first and second ends of the tape respectively.

Abstract: A vaginal insert has a flexible body either in the form of a belt or a split cylinder. In either case, the insert may be coiled into a coiled state. The body has a reduced diameter when coiled and exhibits a resilient bias toward uncoiling and expanding in diameter from the coiled state. When the insert is inserted into the vagina of a patient, it expands and presses against the vaginal wall. This pressure in itself may be therapeutic, e.g., in treating cystocele and incontinence. A medicament may be conjoined with the insert that is introduced to the patient through contact with the insert. The insert can have a simultaneous mechanical and pharmacological effect, e.g., in the instance of treating incontinence with a drug and pressure. The belt-type body may incorporate mating ridges and grooves to keep the insert in a cylindrical configuration. Latch elements may be incorporated on the insert to support the insert in an expanded, partially uncoiled state.

Abstract: The invention relates to a surgical instrument and a method for treating female urinary incontinence. A tape or mesh is permanently implanted into the body as a support for the urethra. In one embodiment, portions of the tape comprise tissue growth factors and adhesive bonding means for attaching portions of the tape to the pubic bone. In a further embodiment, portions of the tape comprise attachment means for fastening portions of the tape to fascia within the pelvic cavity. In both embodiments the tape is implanted with a single incision through the vaginal wall.

Abstract: Described is a surgical instrument and method for treating female urinary stress incontinence. The instrument includes a first curved needle-like element defining in part a curved shaft having a distal end and a proximal, a tape, or mesh, for implanting into the lower abdomen of a female to provide support to the urethra; a second curved needle element having a proximal end and a distal end, and a coupler for simultaneous attachment to the distal end of the first needle and the distal end of the second needle. In an alternate embodiment, the second curved needle is an anesthesia needle and the method includes anesthetizing the needle pathway through a patient's body to facilitate the passage of the first needle and mesh therethrough.

Abstract: A vaginal insert has a flexible body either in the form of a belt or a split cylinder. In either case, the insert may be coiled into a coiled state. The body has a reduced diameter when coiled and exhibits a resilient bias toward uncoiling and expanding in diameter from the coiled state. When the insert is inserted into the vagina of a patient, it expands and presses against the vaginal wall. This pressure in itself may be therapeutic, e.g., in treating cystocele and incontinence. A medicament may be conjoined with the insert that is introduced to the patient through contact with the insert. The insert can have a simultaneous mechanical and pharmacological effect, e.g., in the instance of treating incontinence with a drug and pressure. The belt-type body may incorporate mating ridges and grooves to keep the insert in a cylindrical configuration. Latch elements may be incorporated on the insert to support the insert in an expanded, partially uncoiled state.

Abstract: A woven mesh is provided for supporting tissue or an organ within a female patient's pelvis, and a method for using the same. The mesh includes a central portion having a width, a length, first and second ends, and first and second side edges, and first and second wing portions extending from the first and second ends of the central portion respectively. The first and second wing portions each have a width, a length, and first and second peripheral edges. The width of the wing portions are each greater than the width of the central portion, and when positioned within the female patient, the central portion is positioned below and supports the tissue or organ. A mesh is also provided having woven fibers with voids therebetween, and having a central portion and first and second ends. The average size of the voids at least in the central portion is at least 25-50 mm2, and when positioned within the patient, the central portion is positioned below and supports the tissue or organ.

Abstract: A method is provided for assessing urinary function including removably coupling a first test module to a portable control device, selecting from a plurality of different tests a first test to assess urinary function, the selection being made based on first module identification information obtained by the control device from the test module, and performing the first test. The method may also include one or more of the steps of inserting an insert member coupled to the first test module at least partially into a patient's urinary tract, infusing fluid through the insert member into the urinary tract, and measuring pressure within the urinary tract as fluid is infused therein.

Abstract: A test module is provided for coupling with a control device to form a portable system for assessing urinary function. The test module includes a test module housing, at least one coupling element for removably coupling the test module to the control device, a tubing assembly located at least partially within the test module housing, and a pressure interface in fluid communication with at least a portion of the tubing assembly. When the test module is coupled to the control device, the pressure interface is positioned relative to a pressure sensor in the control device so as to transmit pressure data thereto. The tubing assembly may also couple with a pump device in the control device so as to enable the pump device to pump fluid through the tubing assembly.

Abstract: A medical system is provided for assessing urinary function. The system includes a control device and at least one test module capable of being removably coupled to the control device such that, when coupled, the system is capable of performing a test to assess urinary function. The control device may include a processor and memory having stored therein a plurality of software subroutine, at least one of which directs a test to assess urinary function. The test module may include a module identification device, and the control device selects the software subroutine based upon information obtained from the module identification device. The test module may further include a tubing assembly forming a first fluid conduit between a first fluid inlet and a first fluid outlet and an insert member dimensioned for at least partial insertion into a patient's urinary tract and coupled to the first fluid outlet so that fluid infused through the first fluid conduit flows through the insert member.

Abstract: The surgical instrument according to the present invention includes a tape that includes a netting enclosed by a thin plastic sheath such that insertion is facilitated while avoiding irritation or damage of body tissue. The surgical instrument further includes a shank having a handle at one end thereof, and a curved needle-like element, which is constructed to be connected with the shank to form a curved portion.

Abstract: The method of the present invention relates to treating female urinary incontinence and involves passing opposite ends of a tape into a female patient's body and then positioning at least a portion of the tape between the vaginal wall and the urethra, whereby the tape forms a supportive loop beneath the urethra. The ends of the tape are extended through the patient's abdominal wall and outside of the patient's body and then the position and tension of the supportive loop are adjusted to achieve a clinically acceptable degree of urinary continence.

Abstract: The invention relates to a surgical instrument and a method for treating female urinary incontinence. A tape or mesh is permanently implanted into the body as a support for the urethra. In one embodiment, portions of the tape comprise tissue growth factors and adhesive bonding means for attaching portions of the tape to the pubic bone. In a further embodiment, portions of the tape comprise attachment means for fastening portions of the tape to fascia within the pelvic cavity. In both embodiments the tape is implanted with a single incision through the vaginal wall.